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首页> 外文期刊>The Canadian journal of hospital pharmacy. >Compatibility and Stability of Morphine Sulphate and Naloxone Hydrochloride in 0.9% Sodium Chloride for Injection
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Compatibility and Stability of Morphine Sulphate and Naloxone Hydrochloride in 0.9% Sodium Chloride for Injection

机译：吗啡硫酸盐和盐酸纳洛酮在0.9％注射用氯化钠中的相容性和稳定性

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摘要

Background: Naloxone may be administered in conjunction with morphine to reduce the risk of opioid-induced pruritis. Combining these drugs for coadministration may be beneficial, but little is known about their physical compatibility and stability in combined solutions. Objective: To describe the physical compatibility and stability of morphine sulphate and naloxone hydrochloride (at various concentrations) in IV admixtures. Methods: The physical compatibility and stability of admixtures of morphine 1000 mug/mL and naloxone 4 mug/mL, 12.5 mug/mL, and 25 mug/mL in 0.9% sodium chloride were studied. For each concentration of naloxone, one bag was stored at room temperature (22°C) for 72 h and one bag was stored under refrigeration (4°C) for 30 days. For all preparations, physical characteristics, including pH, colour, and formation of precipitate, were evaluated. The samples were also analyzed by a stability-indicating high-performance liquid chromatographic method. Stability was defined as the retention of at least 90% of the initial concentration. Results: No notable changes in pH or colour and no macroprecipitation were observed in any of the preparations after storage at 22°C for up to 72 h or at 4°C for up to 30 days. All preparations maintained more than 90% of the initial concentrations of morphine and naloxone at the end of the respective study periods. The calculated lower limit of the 95% confidence interval also indicated that 90% or more of the initial concentration remained at the end of each study period. Conclusion: Admixtures of morphine sulphate and naloxone hydrochloride were stable for 72 h at room temperature and for 30 days with refrigeration.
机译：背景：纳洛酮可与吗啡联用，以降低阿片类药物引起的瘙痒症的风险。将这些药物联合给药可能是有益的，但对于它们在混合溶液中的物理相容性和稳定性知之甚少。目的：描述IV混合物中硫酸吗啡和盐酸纳洛酮（各种浓度）的物理相容性和稳定性。方法：研究了在0.9％氯化钠中吗啡1000杯/毫升和纳洛酮4杯/毫升，12.5杯/毫升和25杯/毫升的吗啡混合物的物理相容性和稳定性。对于每种浓度的纳洛酮，一袋在室温（22°C）下保存72小时，一袋在冷藏（4°C）下保存30天。对于所有制剂，均评估了其物理特性，包括pH，颜色和沉淀的形成。还通过指示稳定性的高效液相色谱法分析了样品。稳定性定义为保留至少90％的初始浓度。结果：在22°C下保存72小时或4°C下保存30天后，任何制剂均未观察到pH或颜色的显着变化，也未观察到宏观沉淀。在各个研究期结束时，所有制剂均保持了吗啡和纳洛酮初始浓度的90％以上。计算得出的95％置信区间的下限还表明，在每个研究阶段结束时，仍有90％或更多的初始浓度存在。结论：硫酸吗啡和盐酸纳洛酮的混合物在室温下稳定72小时，在冷藏下稳定30天。

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